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THE MINISTRY OF HEALTH

THE MINISTRY OF HEALTH

DECISION No. 4198/1999/QD-BYT OF DECEMBER 29, 1999 PROMULGATING THE LIST OF FOREIGN-MADE VACCINES AND IMMUNE BIO-PRODUCTS TO BE CONSIDERED BY THE MINISTRY OF HEALTH FOR GRANTING OF REGISTRATION NUMBERS FOR CIRCULATION IN VIETNAM IN 2000

THE MINISTER OF HEALTH

Pursuant to the Government’s Decree No. 68/CP of October 11, 1993 stipulating the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the June 30, 1989 Law on Protection of People’s Health;

Pursuant to the Ministry of Health’s Decision No. 2010/QD-BYT of October 28, 1996 promulgating the Regulation on registration of vaccines and immune bio-products;

At the proposal of the Council for consideration and approval of the registration of vaccines and immune bio-products, at its September 23, 1998 meeting;

At the proposal of the director of the Department of Prophylactic Medicine under the Ministry of Health,

DECIDES:

Article 1.- To promulgate together with this Decision the list of foreign-made vaccines and immune bio-products to be considered by the Ministry of Health for granting of registration numbers for circulation in Vietnam in 2000 (see the list enclosed herewith).

Article 2.- Foreign-made vaccines and immune bio-products already granted registration numbers for circulation in Vietnam shall be permitted to be imported into Vietnam only when they are needed for use.

Article 3.- This Decision takes effect as from January 1st, 2000 and replaces Decision No. 3255/1998/QD-BYT of November 21, 1998.

Article 4.- The Department of Prophylactic Medicine shall have to notify this Decision to enterprises producing and/or trading in vaccines and immune bio-products.

Article 5.- The director of the Ministry’s Office, the director of the Department of Prophylactic Medicine and directors of the concerned departments of the Ministry of Health, the director of the Vietnam Pharmaceutical Management Department, the heads of the units attached to the Ministry, and the directors of the Health Services of the provinces and centrally-run cities shall have to implement this Decision.

Minister of Health
DO NGUYEN PHUONG

THE LIST OF FOREIGN-MADE VACCINES AND IMMUNE BIO-PRODUCTS TO BE CONSIDERED BY THE MINISTRY OF HEALTH FOR GRANTING OF REGISTRATION NUMBERS FOR CIRCULATION IN VIETNAM IN 2000

(Promulgated together with the Health Minister’s Decision No.4198/1999/QD-BYT of December 29, 1999)

Ordinal number

Commodity code

Commodity names

Registration basis

Heading

Subheading

I

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

II

1

2

3

4

5

6

8

III

2

5

6

VI

3002

3002

3002

20

10

90

90

90

-

-

10

50

90

-

-

-

-

-

20

90

30

90

90

90

Vaccines for

- Recombinant hepatitis

- Japanese encephalitis

- Meningococcal meningitis

- Cell rabies

- Measles

- Parotiditis

- Rubeola

- Varicella

- Influenza

- Typhoid

- Haemophilus influenza, of type b

- Diphtheria

- Whooping cough

- Tetanus

- Pneumococcus

Therapeutic bio-products

- Anti-hydrophobic serum

- Anti-venin serum

- Anti-diphtheritic toxin serum

- Anti-tetanic toxin serum

- Assorted immunogenic globulins

- Assorted cytokines (interferon, interleukine)

- Anti-hypersensitive antigens

- Anti-toxin serum

Diagnostic bio-products

- Bio-products for diagnosis of human virus infection

- Bio-products for diagnosis of human bacteria infection

- Bio-products for diagnosis of human parasite infection

- Bio-products for pregnancy diagnosis

- Bio-products for diagnosis of blood groups and a number of blood products

- Bio-products for diagnosis of immune cells (fluorescent antibodies T4, T8...)

Environments for microbial culture

*

*

*

*

* According to standards recognized by the Ministry of Health